The Federal Institute for Drugs and Medical Devices (BfArM) has set out to tender a quantity of 10.4 tonnes of medical cannabis over four years in Germany. However, this quantity is far from sufficient to cover demand. Import dependency is expected to remain.
In the German government’s response to a minor enquiry from the FDP parliamentary group, it was stated that the import demand for medical cannabis has grown to 14 times its size between 2015 and 2019. This year, as in previous years, the BfArM had to apply retroactively for an increase in the import volume, namely of 75 percent. According to the Federal Government, however, supply bottlenecks are not to be expected.
The use of a complicated import procedure instead of strengthening domestic production
The German government regulates the supply of medical cannabis by means of an import procedure requiring approval. In advance, the Federal Opium Agency must report the expected demand to the BfArM and the International Narcotics Control Board (INCB) by the 30th of June.
The estimation of the demand includes medical cannabis flowers for direct delivery to the patient as well as cannabis flowers for the production of extracts, dronabinol and finished drugs. The quantities of cannabis needed for clinical trials and research must also be considered.
“The estimate is based on the consumption data available up to the 30th of June of a given year, their development within the previous year and taking into account the quantities of stocks held by participants in the legal narcotics trade,” says the Federal Government.
The demand for medical cannabis is constantly increasing
The FDP criticises the above-mentioned approach because the demand for medical cannabis is constantly increasing and the estimated quantities are not adjusted. According to the online magazine Apotheke Adhoc, the authorised import volume was 1485 kilograms in 2015, 1500 kilograms in 2016, 10,380 kilograms in 2017, 10,688 kilograms in 2018 and 20,774 kilograms in 2019. In all these years, a re-estimate had to be made because the imported quantity was not sufficient.
The authorised import quantity for 2020 is 16,100 kilograms. This is over four tonnes less than in 2019.
“As this figure is expected to be exceeded before the end of 2020, BfArM has already applied to the INCB for an increase in the quantity as part of a reassessment of the expected additional medical and scientific need for 2020 totalling 12,355 kilograms,” explained the Federal Government.
The INCB has yet to reply.
The Government also stated that there were no plans to increase the quantities cultivated in Germany. According to Apotheke Adhoc, FDP health policy expert Dr. Wieland Schinnenburg criticised that this was a missed opportunity. At the same time, he called for a strengthening of cannabis cultivation in the country.
“The planned harvests in Germany cover only a fraction of the actual demand. We must minimise our dependence on imports and increase production volumes in Germany. The lucrative export market should also be opened up to German companies. There is no reason to discriminate against German companies and exclude them from the world market,” said Dr Schinnenburg.